Pfizer is hiring for the position of Associate I-Reg CMC Strategy in its Regulatory Affairs team. This is an excellent opportunity for postgraduates in Pharmacy or Science looking to begin or develop their career in CMC Regulatory Affairs, post-approval changes, license renewals, and Annual Reports.

The selected candidate will support global regulatory activities related to Chemistry, Manufacturing and Controls (CMC) documentation for renewal applications and Annual Reports across international markets.

Pfizer Associate I-Reg CMC Strategy Job Overview

Job Responsibilities

As an Associate I-Reg CMC Strategy at Pfizer, you will support the Brands CMC Strategist and collaborate with global cross-functional teams to prepare high-quality regulatory submissions.

Renewals CMC Responsibilities

• Support Renewal Strategists in preparing CMC contributions for renewal applications across global markets.
• Author and compile regulatory documentation, including Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A.
• Collaborate with GRS-CMC, RRHS, Pfizer Global Supply, and other cross-functional teams.
• Apply relevant regulatory guidelines while preparing renewal documentation.
• Support the execution of regulatory strategies for product renewals.
• Review technical and supporting documentation for regulatory submissions.
• Update impacted dossier components when required.
• Coordinate Module 1 and Module 3.2.R ancillary documents.
• Coordinate internal document reviews and approval/sign-off activities.
• Identify potential risks and escalate timeline delays appropriately.
• Work with Pfizer regulatory systems, including PEARL, GDMS, PDM, and SPA.

Annual Report CMC Responsibilities

• Review changes implemented during the reporting period for accuracy and completeness.
• Support the development of regulatory strategies for Annual Reports (ARs).
• Prepare and compile CMC contributions for regulatory submissions.
• Review post-approval changes, regulatory commitments, and approvals.
• Review technical and supporting information for Annual Report submissions.
• Manage and review stability-related contributions.
• Apply relevant U.S. regulatory guidelines and Annual Report filing classifications.
• Develop technical justifications for regulatory agency submissions.
• Update regulatory dossier components.
• Coordinate ancillary documentation and internal review processes.
• Ensure compliance with Pfizer internal procedures, SOPs, and training requirements.

Qualifications Required

Candidates applying for the Pfizer Regulatory Affairs job in Chennai should meet the following requirements:

Educational Qualification

• Minimum Preferred Qualification: Postgraduate degree in Pharmacy or Science

Relevant candidates may have advanced academic backgrounds in pharmaceutical sciences and related scientific disciplines.

Experience

• 0–1 years of experience
• Experience or exposure to Regulatory Affairs in a pharmaceutical organization is preferred.

Required Skills

Candidates should have knowledge or understanding of:

• Regulatory Affairs
• CMC Regulatory Strategy
• Post-Approval Changes
• License Renewals
• Annual Reports
• U.S. Regulatory Requirements
• Pharmaceutical Manufacturing
• Regulatory Documentation
• CTD Modules
• Module 1 and Module 3
• Oral Solid Dosage Forms
• Sterile Injectable Products
• Stability Data
• Regulatory Databases
• Technical Documentation
• PEARL, GDMS, PDM, and SPA systems

Key Candidate Attributes

Pfizer is looking for candidates with:

• Excellent written and verbal English communication
• Strong analytical and problem-solving abilities
• Good conceptual and reasoning skills
• Strong organizational skills
• Excellent attention to detail
• Ability to work within defined timelines
• Ability to collaborate with cross-functional teams

Why Join Pfizer?

A career at Pfizer provides an opportunity to work in a global pharmaceutical environment and gain exposure to complex Regulatory Affairs and CMC activities.

Potential career benefits include:

• Exposure to global regulatory submissions
• Experience in CMC Regulatory Affairs
• Opportunity to work with international cross-functional teams
• Learning opportunities in post-approval regulatory processes
• Experience with pharmaceutical regulatory systems
• Career development within a global pharmaceutical organization

Who Can Apply?

This opportunity is particularly suitable for candidates who:

• Have completed a postgraduate degree in Pharmacy or Science
• Are interested in Regulatory Affairs
• Want to build a career in CMC Regulatory Strategy
• Have 0–1 years of relevant experience
• Understand pharmaceutical manufacturing and regulatory documentation
• Are interested in global pharmaceutical regulatory submissions

How to Apply

Application Link